Patient information on drug therapy. A problem of medical malpractice law: between product safety and user safety

Medicinal products are associated with risks as well as potential therapeutic benefits. This is reflected by the legal requirements for patient information on drug therapy which can be differentiated into general product information, regulated by pharmaceutical (i. e. product safety) law, and individual patient information on the treatment with the product, which is subject to medical malpractice law. The physician's duty to inform the patient comprises therapeutic information as well as information required for informed consent. Therapeutic information intends to empower the patient to comply with the requirements of treatment and to protect him/her against preventable danger and risk; it is part of the medical treatment, aimed at the individual patient and his/her personal situation. Information required for informed consent enables the patient to a self-determined decision on the treatment offered; it can be divided into information on the course of treatment and risk information. Product information and treatment information complement each other; the former should be the basis of individual information on the concrete treatment, provided by the physician in a mandatory oral conversation with the patient. Product information cannot replace the physician's individual information about the treatment.     

Giving the reasonable patient a voice: information disclosure and the relevance of empirical evidence

In England the standard of risk disclosure required of doctors to avoid liability in negligence is governed by the Bolam test. The test is determined by what would be accepted as reasonable by the responsible doctor. Although able to lay down an independent standard, the courts have usually been guided by the medical expert's evidence. The judge's duty to scrutinise expert evidence was reaffirmed by the recent House of Lords ruling in Bolitho v City and Hackney HA. In Pearce v United Bristol Healthcare NHS Trust, Lord Woolf MR confirmed that this also applied to risk disclosure. Brazier & Miola argue that Pearce effectively introduces the prudent patient standard into English law. This paper examines that claim and considers whether it is justified by the Pearce judgment. The implications of Pearce are explored and, given the appeal to the concept of a material risk, I discuss the relevance of empirical research to determining the standard of disclosure. Finally, a small piece of empirical work is presented as an illustration of the pros and cons of such an approach and as a possible springboard for future research.     

Abortion, breast cancer, and informed consent

The purpose of this article is to show that the current level of scientific evidence linking induced abortion with increased breast cancer risk is sufficient to support an ethical and legal duty to disclose fully the risk to women who are considering induced abortion. The article examines the relationship between this evidence and the elements of a medical malpractice claim alleging failure to obtain informed consent. The first part focuses on the elements of informed consent, which require the plaintiff to establish that the physician had a duty to disclose information, which he failed to disclose, that this failure to disclose was a legal cause of the plaintiff's decision to undergo the procedure, and the procedure was a legal cause of the plaintiff's injury. The second part compares two prevalent standards for determining which risks a physician has a duty to disclose. Part three reviews the scientific evidence of the abortion/breast cancer (ABC) link and explains why it survives both the Frye and the Daubert tests for admissibility of expert testimony. The fourth part assesses the materiality of the risk posed by the ABC link. Parts five and six discuss evidentiary issues and the possibility of punitive damage awards.     

Excessive risk disclosure: the effects of the law on medical practice

This article examines the debate surrounding the challenging concept of informed consent. It argues whilst the English courts have effectively excluded the use of the tort of battery as an appropriate mechanism for protecting a patient's right to self-determination, they have left the law in a state of flux due to the uncertainties associated with categorising similar claims within negligence where the onus is on risk disclosure. This confusion may stem firstly from the fact that medical practitioners are unsure exactly which risks to disclose, and secondly, from the way in which both doctors and patients perceive the consent process. The paper suggests this disorder may be having a detrimental effect on medical practice as medical practitioners are taking it upon themselves to disclose excessive information, which patient's may not want or need. A suggestion is also made that in these situations, in order that the law truly respects self-determination, consideration must be given to the patient's desire to waive their right to informed consent.     

司法何以如此尴尬——以一起医疗纠纷案件审理为例

不断增多的医疗纠纷及其引发的种种愤懑,使得各种利益纠葛、体制冲突、伦理诉求和法律管制之间形成了一种较之从前更为复杂而微妙的关系。对医患关系的社会调查显示,目前我国医患双方的关系并不融洽,双方缺乏高度的信任感,一旦患者未达到其预期的疗效,势必为双方的矛盾、冲突和纠纷埋下伏笔;医患双方在具体运用知情同意权法则时产生的强烈的错位,使得知情同意权在减少医患纠纷、构建高度信任基础上的医患和谐关系的功能大打折扣。而对实践中的一个真实案例的审理的剖析则反映出我国法律和司法在知情同意权方面是如此的苍白无力,使得知情同意法则的建立迫在眉睫。我国知情同意权法则的理想构架应该包括:知情同意权法则的基本原则,医生的告知义务,患者的同意以及违反告知义务的构成要件。     

The federal government and academic texts as barriers to informed consent

Informed patient consent for medical treatment is required by both law and medical ethics. Yet, both federal agencies and academicians are participating in the suppression of information about the heightened risk of breast cancer posed by oral contraceptives and induced abortion. There is historical precedent in the long-delayed acknowledgement of the smoking/lung cancer link. By law, a patient has the right to be fully informed of the nature of her medical condition and any proposed course of therapy. It is assumed that a patient will be given the complete and true scientific basis of her diagnosis and treatment, to ensure that her well-being and her autonomy in decision-making are protected. Informed consent is the process by which a patient can participate in choices about medical treatment. It originates from the legal and ethical right of the patient to direct what is done to her body, and from the ethical duty of the physician to involve the patient in her medical care. Our federal government has become a barrier to informed consent concerning oral contraceptive drugs and induced abortion.     

No (,) More Bolam Please: Montgomery v Lanarkshire Health Board

Montgomery v Lanarkshire Health Board concerned a negligent non‐disclose of certain risks involved in natural birth. The Supreme Court departed from Sidaway v Bethlem Royal Hospital, which formerly governed negligent risk disclosure. A new test was adopted: risks that are material must be disclosed, the materiality of a risk to be decided by reference to a reasonable person in the patient's position, or where the medical professional should be reasonably aware a particular patient is likely to attach significance to that risk. The Court emphasised risk disclosure practices must focus on what the patient wants to know. Yet the Court's portrayal of this change as a development of Sidaway is questionable. The decision is problematic in its engagement with precedent, the new test's future implications and statements regarding therapeutic privilege. Despite rejecting Bolam v Friern Hospital Management Committee's relevance to risk disclosure, this case is likely to remain relevant.     

'The good that is interred in their bones': are there property rights in the child?

Bone marrow donation between siblings is a common medical procedure. In some instances, the donor will be a young child incapable of providing either consent or assent, and the intervention is made lawful through the consent of the parent(s). Although a number of justifications have been formulated to cover this act with legitimacy, these fail to describe accurately the transaction that takes place. In the absence of the child authorising his parents to act as his proxy, it is unclear why parental consent is sufficient to permit the redistribution of his biological wealth. Instead, where the donor is such a young child, the whole procedure may be construed as the appropriation of bodily tissue from one unconsenting human and its conveyance to a third, albeit related, party. This paper argues that if the parentally authorised transfer of biological material from an unconsenting human to another is legally permissible, it must be on the basis of an implicitly acknowledged property right in the child.     

From Responsible Disclosure Policy (RDP) towards State Regulated Responsible Vulnerability Disclosure Procedure (hereinafter – RVDP): The Latvian approach

Cybersecurity is an integral part of security. It plays a tremendous role in modern society. It encompasses technical, organizational and legislative measures created for the purpose of protecting and minimizing impacts from cyber incidents. Any software may contain bugs or security holes. Hackers frequently discover such flaws and, without vendor's consent, disclose step-by-step instructions about vulnerability to the public, disregarding the possible IT security risk. Many vendors already have introduced responsible disclosure policies or “bug bounty” programs. In 2013 the Netherlands launched the first state responsible disclosure Guidelines. Guidelines contain principles, definitions and organizational measures, necessary for responsible disclosure policy as a state policy.Latvia decided to draft Regulation on responsible disclosure procedure. In March 2016, the Ministry of Defence created a working group. The goal of the drafters was: 1) to prepare amendment to Law on the Security of Information Systems to create legislative framework for responsible vulnerability disclosure process; 2) to draft an amendment to Section 241 (3) of Criminal Law to create a guaranty against prosecution (waiver) for persons who act in accordance with responsible disclosure process. The paper provides an insight into this process, difficulties faced by drafters and presents provisional results of the legislative draft and lessons to be learnt.     

Misusing informed consent: a critique of limitations on research subjects' access to genetic research results

Express denials of access to genetic research results are being drafted into consent instruments. Some commentators suggest that the principle of beneficence can justify such a denial of access. This paper provides an ethical and legal critique of the use of consent instruments to disclaim responsibility for on-going disclosure by genetic researchers. Currently, the law of torts provides only weak protection for on-going disclosure for research subjects. The most substantive rights are to be found in the law of fiduciary obligations. The author concludes that, notwithstanding arguments to the contrary, there should be a presumption of disclosure in genetic research, unless the research subject elects otherwise. The author outlines one possible exception to this general presumption.     

Keeping mum about dad: "contracts" to protect gamete donor anonymity

This article considers the legal status of so-called contracts for anonymity between fertility clinics and donors of gametes that were made in the period before legislation authorising disclosure. It notes that while clinics frequently cite the existence of these "contracts" to argue against retrospective legislation authorising disclosure of the donor's identity, they may be nothing more than one-sided statements of informed consent. However, the article notes that even if an agreement between a donor and a clinic is not contractual, it does not follow that a person conceived through assisted reproductive technology has any right of access to the identity of the donor. The writer has not been able to locate examples of written promises by the clinics promising anonymity. There are written promises by the donors not to seek the identity of the recipients. These promises do not bind the resulting offspring nor do they appear to be supported by consideration. The article suggests that the basis for any individual donor to restrain a clinic from revealing their identity may be found in promissory estoppel. Nevertheless, there is no real issue in Australia concerning clinics revealing these details absent legislative authority. The issue is whether parliaments will legislate to authorise the disclosure. The article notes that it would be rare for parliaments to legislate to overturn existing legal contracts but suggests that the contract argument may not be as strong as has been thought.     

《侵权责任法》中患者近亲属知情同意评析

《侵权责任法》在患者知情同意制度中使用了“近亲属”这一概念,并在第五十五条提出：“不宜向患者说明的,应当向患者的近亲属说明。”此提法不仅与国外“病人自治”原则存有差异,而且“近亲属”这一概念范围也不明确。本文拟对第五十五条立法中所体现的“近亲属知情同意”的合理性以及“近亲属”这一概念使用的恰当性进行探讨。     

论医疗民事责任的判定--医方承担医疗民事责任的范畴及认定标准

本文指出医方承担医疗民事责任的范围不应仅仅局限于医疗事故,还应包括其他一些因医方医疗行为所导致患者合法权益受损害的民事赔偿责任.从承担医疗违约责任和医疗侵权责任两个方面来讨论医疗民事责任,主张引进"善良注意义务"的医疗判断标准;将医方的告知义务区分为必须的告知义务与一般的告知义务,认为医方只对违反了必须的告知义务才承担相应的民事责任.     

To Disclose or not to Disclose? That is the Question in Collaborative Law

Collaborative Law (CL) is a dispute resolution process increasingly used in family law and divorce designed to encourage problem solving negotiations by parties represented by counsel. Many states have adapted legislation to authorize and facilitate CL and thousands of lawyers have been trained in the CL process. CL lawyers and participants sign a Participation Agreement in which they agree that the lawyers will be disqualified if the CL process terminates without settlement. They also promise full and voluntary disclosure of information. The extent of the obligation of disclosure is, however, unclear. Through analysis of an extended hypothetical divorce settlement negotiation, this article advocates that CL lawyers and clients should assume an obligation to disclose material facts without a request from the other side. Traditional legal ethics, based on an adversarial framework, requires only disclosure of information when requested by another party. In addition, in traditional legal ethics, a lawyer cannot disclose information obtained in the course of the lawyer‐client relationship without the client's consent even if material to the negotiation. Some authority regulating CL, however, suggests that CL participants and counsel should disclose material information without a specific request even if a client does not want the information disclosed. In that situation, the CL lawyer should encourage the client to disclose the information but if the client refuses to do so, withdraw from the representation. This Article reviews the arguments for and against an obligation of affirmative disclosure in CL. It suggests that affirmative disclosure obligations should be the subject of discussion between CL participants and lawyers and that CL Participation Agreements should be drafted to establish a clear obligation. Finally, this article identifies key areas for further discussion and research on CL disclosure obligations.     

The Data Protection (Amendment) Act, 2003: the Data Protection Directive and its implications for medical research in Ireland

Directive 95/46/EC on the Protection of Individuals with regard to the Processing of Personal Data and on the Free Movement of Such Data has been transposed into national law and is now the Data Protection (Amendment) Act, 2003. The Directive and the transposing Act provide for new obligations to those processing data. The new obligation of primary concern is the necessity to obtain consent prior to the processing of data (Article 7, Directive 95/46/EC). This has caused much concern especially in relation to 'secondary data' or 'archived data'. There exist, what seem to be in the minds of the medical research community, two competing interests: (i) that of the need to obtain consent prior to processing data and (ii) the need to protect and foster medical research. At the same time as the introduction of the Act, other prior legislation, i.e. the Freedom of Information Act, 1997-2003, has encouraged candour within the doctor-patient relationship and the High Court in Ireland, in the case of Geoghegan v. Harris, has promulgated the 'reasonable-patient test' as being the correct law in relation to the disclosure of risks to patients. The court stated that doctors have a duty to disclose all material risks to patients. The case demonstrates an example of a move toward a more open medical relationship. An example of this rationale was also recently seen in the United Kingdom in the House of Lords decision in Chester v. Afshar. Within the medical research community in Ireland, the need to respect the autonomy of patients and research participants by providing information to such parties has also been observed (Sheikh A. A., 2000 and Irish Council for Bioethics, 2005). Disquiet has been expressed in Ireland and other jurisdictions by the medical research communities in relation to the exact working and meaning of the Directive and therefore the transposing Acts (Strobl et al). This may be due to the fact that, as observed by Beyleveld "The Directive makes no specific mention of medical research and, consequently, it contains no provisions for medical research as an explicitly delineated category." (Beyleveld D., 2004) This paper examines the Irish Act and discusses whether the concerns expressed are well-founded and if the Act is open to interpretation such that it would not hamper medical research and public health work.     

Unwarranted variations in the quality of health care: can the law help medicine provide a remedy/remedies?

This Article reviews the essential findings of studies of variations in quality of care according to three categories of care: effective care, preference-sensitive care, and supply-sensitive care. It argues that malpractice liability and informed consent laws should be based on standards of practice that are appropriate to each category of care. In the case of effective care, the legal standard should be that virtually all of those in need should receive the treatment, whether or not it is currently customary to provide it. In the case of preference-sensitive care, the law should recognize the failure of the doctrine of informed consent to assure that patient preferences are respected in choice of treatment; we suggest that the law adopt a standard of informed patient choice in which patients are invited, not merely to consent to a recommended treatment, but to choose the treatment that best advances their preferences. In the case of supply-sensitive care, we suggest that physicians who seek to adopt more conservative patterns of practice be protected under the "respectable minority" or "two schools of thought" doctrine.     

AIDS-related risks in the health care setting: HIV testing of health care workers and patients

Do patients and health care workers have the legal right to know each other's HIV status? Professor Flanagan argues that they do not. Given that with appropriate precautions the risk of transmitting HIV in the health care setting is extremely small and that the discriminatory consequences of HIV disclosure can be extremely high, it is suggested that the right of a patient or a health care worker not to disclose their HIV status must outweigh the other's "right to know."     

Extending the Practice of Physician‐Assisted Suicide to Competent Minors

In an effort to address the mental and physical suffering terminally ill patients endure, some states have either legalized or decriminalized physician‐assisted suicide—a practice commonly referred to as death with dignity. However, as the practice of physician‐assisted suicide becomes accepted among states, competent minors continue to be excluded from legislative and judicial decisions. Regardless of parental consent, states institute an age requirement of eighteen years old for participants of physician‐assisted suicide. This Note proposes that states amend their physician‐assisted suicide statutes to (1) remove any age restriction, (2) create a standard of competency that minors must meet to be eligible for physician‐assisted suicide, and (3) implement a procedure to determine whether a minor meets the competency standard.     

Reshaping informed consent in the biobanking context

In my article, I discuss the role of informed consent in the context of biobanking. I argue that the basic issue in understanding the role of the consent is one of identifying the interests at stake and determining which of these interests we intend to promote. The definition of the informational content represents only a consequential step. For this purpose, I analyse the legal status of human biological materials from three different perspectives: "material", "informational" and "relational". Informed consent produces different effects on each of these perspectives. From the material perspective, consent can influence the allocation of property rights over human tissue; from the informational point of view, consent is the legal instrument that permits control over personal data; while from the "relational" perspective, it is possible through consent to ensure that the person's personal beliefs are respected. The crucial point is that the legal effects that informed consent has on the three perspectives overlap. Therefore, in order to understand the role of informed consent holistically, in this article I analyse how these perspectives relate to each other. This analysis shows that the relationship between the perspectives can vary depending on the interests that we intend to promote. If we intend to promote the freedom of research, then the material dimension can prevail, whilst if we focus our attention on the interests of individuals then the informational and the relational dimensions will prevail. The challenge is to find a good balance between these two extremes.